• Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met.
• Release batches through ERP system.
• Assist with monitoring the FMS system and generating FMS weekly report.
• Draft, review or approve sampling instructions, quality assurance procedures, and standard operating procedures.
• Ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
• Review and approve investigations of reprocessing/rework of products, analytical failures, and returns/salvages.
• Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
• Supporting or performing internal audits.
• Supporting external regulatory or customer audits.
• Supporting or performing supplier audits.
• Gather information from multiple departments for trending and presentation to management.
• Identify trends in the industry and recommend improvements.
• Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control.
• Other duties as assigned to ensure appropriate quality practices.

Experience & Necessary Skills:

• Knowledge and experience with the cGMPs, preferably in a commercial compounding outsource facility
• Able to identify potential adverse issues
• Excellent organization and documentation skills
• Detail oriented.
• Computer skills, including Microsoft Word and Excel
• BS or BA degree (in a scientific discipline desired)

Benefits:

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & HSA
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program 

Shift Monday-Friday 2nd Shift (3:30pm - 12:00am)

Timeline: We will be accepting applications on an ongoing basis until position is filled. 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.